A Study to Evaluate Efficacy and Safety of Cabotegravir (... | NCT04542070

Name	Class
Janssen, LP	INDUSTRY

Label	Type	Description	Intervention Names
Biktarvy (BIK)	Active Comparator	Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).	Drug: BIKTARVY Tablets (BIK)
Oral lead-in phase (OLI)	Experimental	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase	Drug: Cabotegravir Tablets Drug: Rilpivirine Tablets
Direct to injections (D2I)	Experimental	Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.	Drug: Cabotegravir Injectable Suspension (CAB LA) Drug: Rilpivirine Injectable Suspension (RPV LA)
Switch Q2M Group	Active Comparator

Name	Type	Description	Arm Group Labels	Other Names
Cabotegravir Tablets	Drug	CAB tablets were available as film coated tablets for oral administration.	Oral lead-in phase (OLI)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population	Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.	At month 12/11
Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population	Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.	At month 12/11

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population	Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.
A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies.
1. Non-reproductive potential defined as:
  - Pre-menopausal females with one of the following:
    1. Documented tubal ligation.
    2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion.
    3. Hysterectomy.
    4. Documented Bilateral Oophorectomy
  - Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. If BIK is the second regimen, the first regimen must be an integrase inhibitor (INI) regimen. Only a single prior Integrase inhibitor (INI) regimen is allowed if BIK is a second line regimen >=6 months prior to screening. Any history of non-integrase strand transfer inhibitor regimens (that is. non-nucleoside reverse transcriptase inhibitor, protease inhibitor, C-C chemokine receptor 5 and other entry inhibitors) are not permitted. Any prior change in regimen, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for treatment failure (HIV-1 RNA >=400 c/mL).

The following are limited exceptions:

A change from Tenofovir disoproxil fumarate (TDF) to TAF will not be considered a regimen change.
Historical perinatal use of Nucleoside reverse transcriptase inhibitor (NRTI) when given in addition to an ongoing Highly active antiretroviral therapy (HAART) will not be considered a change in ART therapy regimen.
The past use of ARVs in the context of Post Exposure Prophylaxis (PEP) or Pre-Exposure Prophylaxis (PrEP) while the participant was HIV negative will be allowed. Such cases will be evaluated on a case by case basis with the Medical Monitor, and may require documentation of HIV negative serology during time of PEP or PrEP.
A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.
A change in formulation from multiple class regimens to single treatment regimens (of the same medications) would not be considered a change in ART regimen.
- Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening.
- Plasma HIV-1 RNA <50 c/mL at Screening.

Exclusion Criteria:

Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL.
Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement greater than (>)200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
History of prior treatment failure to any Department of Health and Human Services (DHHS) recommended ART regimen.
History of drug holiday >1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns.
Any change to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=200 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).
Participants who are currently participating in or anticipate being selected for any other interventional study.
Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/microliter are not exclusionary.
Participants with moderate to severe hepatic impairment.
Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment.
All participants will be screened for syphilis.
- Participants with untreated secondary (late latent) or tertiary syphilis infection, defined as a positive rapid plasma reagin (RPR) and a positive treponemal test without clear documentation of treatment, are excluded.
- Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor.
- Participants with primary syphilis or early latent secondary syphilis (acquired within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be completed before the screening window ends, participants may be rescreened once following completion of antibiotic therapy for primary or early latent secondary syphilis.
Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
The participant has a tattoo, gluteal implant/enhancements or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows:
1. Participants positive for HBsAg are excluded.
2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded.
Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded for those co-infected participants who post entry into Switch Onto Long Acting Regimen (SOLAR) decide treatment for HCV infection is warranted or desired either by the participant or by the treating physician.

Participants with HCV co-infection will be allowed entry into this study if:

Liver enzymes meet entry criteria
HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Month 14 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis (Fib)-4 score will be used to verify eligibility

i. Fib-4 score >3.25 is exclusionary ii. Fib-4 scores 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: d. Age x aspartate aminotransferase (AST)/ Platelets x (square [Alanine aminotransferase {ALT}]).

Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis [for example {e.g.} ascites, encephalopathy, or variceal bleeding]), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
History of liver cirrhosis with or without hepatitis viral co-infection.
Ongoing or clinically relevant pancreatitis
Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization.
Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 milligram) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
Corrected QT interval (QTc [Bazett]) >450 milliseconds (msec) or QTc (Bazett) >480 msec for participants with bundle branch block.
Known or suspected active Coronavirus Disease-2019 (COVID-19) infection or has had contact with an individual with known COVID-19, within 14 days of study enrollment.
Known or suspected presence of resistance mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any historical resistance test result.
Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
Participant has estimated creatine clearance <30mL/minute per 1.73 meter square (m^2) via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method.
ALT >=3 times upper limit of normal (ULN).
Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.
Treatment with any of the following agents within 28 days of Screening:
- radiation therapy;
- cytotoxic chemotherapeutic agents;
- tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid/INH);
- anti-coagulation agents;
- Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1. Treatment with acyclovir/valacyclovir is permitted.
Use of medications which are associated with Torsade de Pointes.
Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bakersfield	California	93301	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
36626155	Background	Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.
37567205

ID	Title	Description
FG000	Oral lead-in Phase (OLI)	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 10, 2022	Jul 12, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population

Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent-to-treat exposed (ITT-E) population included all randomized participants who receive at least one dose of IP during the Maintenance Phase of the study (on or after Day 1).

Posted

Number

95% Confidence Interval

Percentage of participants

At month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.
OG001	Biktarvy (BIK)	Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Units	Counts
Participants	OG000454 OG001227

Title

Denominators

Categories

Title	Measurements
	OG0001.3(0.5 to 2.9) OG0010.4(0.0 to 2.4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in percentage	0.9			2-Sided	95	-0.5	2.2			Difference in percentage = percentage of Q2M - percentage of BIK		Non-Inferiority	Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.

Primary

Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population

Modified intent-to-treat exposed (mITT-E) population included all ITT-E participants (that is all randomized participants who received at least one dose of IP during the Maintenance Phase of the study [(on or after Day 1])) excluding those from a GSK Investigational site where Good Clinical Practice noncompliance was observed.

Posted

Number

95% Confidence Interval

Percentage of participants

At month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population

Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent-to-treat exposed (ITT-E) population.

Posted

Number

95% Confidence Interval

Percentage of participants

At month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population

Modified intent-to-treat exposed (mITT-E) population

Posted

Number

95% Confidence Interval

Percentage of participants

At month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population

Percentage of participants with plasma HIV 1 RNA < 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent-to-treat exposed (ITT-E) population

Posted

Number

95% Confidence Interval

Percentage of participants

At month 6/5

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population

Modified intent-to-treat exposed (mITT-E) population

Posted

Number

95% Confidence Interval

Percentage of participants

At month 6/5

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11

Protocol-defined confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >= 200 c/mL (Day 1 values are not applicable) after prior suppression to <200 c/mL. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at Month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Cumulative number of participants with protocol defined CVF through Month 6/5 and 12/11 has been presented.

Modified intent-to-treat exposed (mITT-E) population

Posted

Count of Participants

Participants

Up to month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5

Percentage of participants with plasma HIV 1 RNA >= 50 c/mL at month 6 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Modified intent-to-treat exposed (mITT-E) population

Posted

Number

95% Confidence Interval

Percentage of participants

At month 6/5

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Absolute Values of HIV Viral Load

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

log10 copies per milliliter(c/mL)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in HIV Viral Load

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

log10 c/mL

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

cells per cubic millimeter(cells/mm^3)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in CD4+ Cell Count

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

cells/mm^3

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11

Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

Confirmed Virologic Failure (CVF) population included all participants in the ITT-E population who met Confirmed Virologic Failure (CVF).

Posted

Count of Participants

Participants

Up to Month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5

Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

Confirmed Virologic Failure (CVF) population.

Posted

Count of Participants

Participants

Up to Month 6/5

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11

Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

Confirmed Virologic Failure (CVF) population.

Posted

Count of Participants

Participants

Up to Month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.
OG001

Secondary

Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5

Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

Confirmed Virologic Failure (CVF) population.

Posted

Count of Participants

Participants

Up to Month 6/5

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.
OG001

Secondary

Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L))

Serum samples were collected to evaluate bone specific biomarkers: specific alkaline phosphatase, procollagen type 1 N-propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety Population included all randomly assigned participants who received at least one dose of study drug. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

micrograms per liter (ug/L)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L))

Serum samples were collected to evaluate bone specific biomarkers: serum 25-hydroxyvitamin D. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

nanomoles per liter (nmol/L)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L])

Serum samples were collected to evaluate renal specific biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

milligrams per liter (mg/L)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L))

Serum samples were collected to evaluate renal specific biomarkers: urine phosphate. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L))

Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein 4. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

microgram per liter (ug/L)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol))

Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein/creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

milligram per mole (mg/mol)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol))

Serum samples were collected to evaluate renal specific biomarkers: urine beta-2 microglobulin/ creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

grams per mole (g/mol)

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11

Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Number

Percentage of participants

Baseline (Day 1) and at Month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5

Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Number

Percentage of participants

Baseline (Day 1) and at month 6/5

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR)

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. HOMA-IR is calculated as fasting insulin microunits per liter (microU/L) multiplied by fasting glucose (nmol/L) divided by 22.5. Higher HOMA-IR values indicate increased insulin resistance; values <2 is generally regarded as normal. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Safety population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

HOMA-IR score

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M

Participants who had switched from the daily oral BIK regimen to CAB + RPV, were assessed as per the preference questionnaire every two months. There were 3 preference questions included to assess the preferred treatment 1) Long-acting injectable HIV medication, 2) Daily oral HIV medication, 3) No Preference. This endpoint was only planned to be analyzed for Q2M arm only. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Data represented included maintenance withdrawal or Month 12/11.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Number

Percentage of participants

Up to month 12/11

ID	Title	Description
OG000	Oral lead-in Phase (OLI)	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.
OG001	Direct to Injections (D2I)

Secondary

Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)

The HIVTSQs total treatment satisfaction score comprised of 11 items based on HIVTSQ questionnaire each graded on a scale of 0 (very dissatisfied) to 6 (very satisfied) which were summed to produce a total score range of 0-66. Higher scores represent greater treatment satisfaction. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Scores on scale

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Baseline in Individual Item Scores Using HIVTSQs

The individual item scores on HIVTSQs scale were rated on a scale of 6 (very satisfied, convenient, flexible, etc.) to -6 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Scores on scale

Baseline (Day 1) and up to Month 12

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11

HIV treatment satisfaction change questionnaire (HIVTSQc) total Score is computed with items 1-11 which were summed to produce a total score range of -33 to 33. Higher score indicated greater improvement in the satisfaction with the treatment and lower score indicated greater deterioration in treatment satisfaction. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified Intent-to-Treat Exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Scores on scale

At Month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Individual Item Scores of HIVTSQc at Month 12/11

Individual item scores were rated on a scale of +3 (much more satisfied', 'much more convenient', 'much more flexible') to -3 (much less satisfied', 'much less convenient', 'much less flexible'). Higher score indicates greater improvement, and lower score indicates greater deterioration in satisfaction with each aspect of treatment. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Scores on scale

At Month 12/11

ID	Title	Description
OG000	Q2M (OLI + D2I)	Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.

Secondary

Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M

The PIN questionnaire was used to explore the dimension scores based on 4 dimensions including acceptance of injection site reactions (ISRs), Bother from ISRs, Leg movement and Sleep categories. Domain scores were calculated as a mean of all items with the domain. The PIN response options range from 1 (totally acceptable) to 5 (not at all acceptable). This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Scores on scale

From Month 2/1 up to Month 12

ID	Title	Description
OG000	Oral lead-in Phase (OLI)	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.

Secondary

Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M

The PIN questionnaire was used to explore the individual item scores based on anxiety before, pain, satisfaction, anxiety after and willingness categories. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is very dissatisfied and 5 was very satisfied. This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Scores on scale

From Month 2/1 up to Month 12

ID	Title	Description
OG000	Oral lead-in Phase (OLI)	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG0030 events0 affected145 at risk
COVID-19	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0021 events1 affected227 at risk EG003
Respiratory tract infection	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Anal abscess	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Appendicitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
COVID-19 pneumonia	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Herpes simplex meningitis	Infections and infestations	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Herpes simplex meningoencephalitis	Infections and infestations	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Pyelonephritis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Tonsillitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Tuberculosis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Abdominal injury	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Overdose	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0022 events2 affected227 at risk EG003
Contusion	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Blood creatine phosphokinase increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Alanine aminotransferase increased	Investigations	v24.1	Systematic Assessment	EG0002 events2 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Obesity	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Syncope	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Brain injury	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Encephalopathy	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Haemorrhagic transformation stroke	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Device breakage	Product Issues	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Drug abuse	Psychiatric disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Substance abuse	Psychiatric disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Acute kidney injury	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Urinary retention	Renal and urinary disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Acute myocardial infarction	Cardiac disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Atrial fibrillation	Cardiac disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Anorectal disorder	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Injection site pain	General disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Pyrexia	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0021 events1 affected227 at risk EG003
Cholecystitis	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Abortion induced	Surgical and medical procedures	v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected279 at risk EG0020 events0 affected227 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Hepatitis C	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Sudden death	General disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected279 at risk EG0020 events0 affected227 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
C584914	cabotegravir
D000068696	Rilpivirine
C000654125	bictegravir, emtricitabine, tenofovir alafenamide, drug combination

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Oral lead-in Phase (OLI)	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.
BG001	Direct to Injections (D2I)	Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.
BG002	Biktarvy (BIK)	Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oral lead-in Phase (OLI)	Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.	0	175	11	175	156	175
EG001	Direct to Injections (D2I)	Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.	0	279	10	279	257	279
EG002	Biktarvy (BIK)	Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).	1	227	15	227	77	227
EG003	Switch Q2M Group	Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.	1	145	5	145	76	145